Development
Conditions
Keywords
Formula Feeding, Mother, Moms, Infants, Babies, Baby, growth, energy balance
Brief summary
The overarching goal of the research we propose here is to conduct a randomized clinical trial to specify the physiologic and behavioral mechanisms by which infant-formula composition affects all aspects of energy balance and growth during the first years of life.
Detailed description
This is a randomized clinical trial of infants whose parents decided to formula feed them; mother-infant dyads will be randomized when infant is 2 weeks of age to one of 2 groups. The groups will differ in the composition of the formula fed to the infant during the first year of life.
Interventions
OTHERType of Formula
infant formula
Sponsors
University of Delaware
Children's Hospital of Philadelphia
University of Wisconsin, Madison
Monell Chemical Senses Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Between- and within-subject longitudinal trial
Eligibility
Sex/Gender
ALL
Age
1 Weeks to 3 Weeks
Healthy volunteers
Yes
Inclusion criteria
1. A healthy, term (≥37 and ≤42 week gestation at birth), singleton infant. 2. Birth weight between 2500 - 4500 grams. 3. At the time of enrollment, infant must be ≤14 days old (Date of birth=day 0). 4. Mother must be 18 years or older. 5. Infant must be consuming a standard cow's milk protein infant formula and have been receiving a standard cow's milk protein infant formula for at least the past 2 days prior to enrollment.
Exclusion criteria
1. Mother had gestational diabetes during pregnancy 2. Infant has condition requiring infant feedings other than feeding cow milk formula from a bottle. 3. Infant has major congenital malformations (i.e. cleft palate, hemangiomas, extremity malformation). 4. Infant has suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus). 5. Infant has evidence of significant cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases. For example, infant must not be receiving insulin or growth hormone. 6. Dyad be the relative (son, daughter, niece, nephew, cousin, aunt, uncle, sibling) of ancillary personnel connected with the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Energy Balance: Energy Loss in Stools | 0.75, 3.5, 12.5 mos | Stool EL (kcal/day) was determined from 3-day stool collection by bomb calorimetry at each timepoint |
| Growth, Weight for Length (WLZ) Z Scores | 0.5 to 12.5 months with followup visit at 18.5 mos | At each visit, infants were weighed and measured to monitor normal growth. These anthropometric data were converted to weight-for-length (WLZ) Zscores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum). |
| Growth, Weight for Age (WAZ) Z Score | 0.5 to 12.5 months with followup visit at 18.5 mos | At each visit, infants were weighed to monitor normal growth. These anthropometric data were converted to Weight for age Z (WAZ) Z scores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum). |
| Growth: Length for Age (LAZ) Z Scores | 0.5 to 12.5 months with followup visit at 18.5 mos | At each visit, infants were measured to monitor normal growth. These anthropometric data were converted to Length for age Z (LAZ) Z scores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum). |
| Energy Balance: Energy Intake From Infant Formula and Other Sources | 0.75, 3.5, 12.5 mos | Energy intake (kcal/day) of infant formula and other sources was determined by three-day weighed bottle intake and records of the infants' intake of any liquid or food other than formula during the three days |
| Energy Balance: Sleeping Energy Expenditure (SEE) | 0.75, 3.5, 12.5 mos | Postprandial SEE (kcal/day), a proxy for resting energy expenditure in infant, was measured for a minimum of 30 min by open-circuit, indirect calorimetry using a metabolic cart with canopy hood, in a quiet, thermal-neutral room. |
| Energy Balance: Total Energy Expenditure (TEE) | 0.75, 3.5, 12.5 mos | TEE (kcal/day) was measured over 7 days at each of the three time points (0.75, 3.5 and12.5 mos) using the doubly labeled water method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feeding Behaviors, Maternal Perceptions | 0.5 months | Maternal perception of infant feeding behavior, using standardized questionnaires (Infant feeding style questionnaire; IFSQ); values ranged from 1 to 5; higher scores reflect more of that feeding style. Only baseline data reported herein. |
Countries
United States
Participant flow
Recruitment details
From 2012 to 2015, newly parturient women whose decision not to lactate was firmly established were recruited through ads in regional newspapers, websites and hospitals in the greater Philadelphia area.
Participants by arm
| Arm | Count |
|---|---|
| Type of Formula: CMF infant is randomized to feed standard cow milk infant formula \[CMF\] during first year of life
Type of Formula: infant formula | 59 |
| Type of Formula: EHF infant is randomized to feed extensively hydrolyzed protein infant formula \[EHF\] first year of life
Type of Formula: infant formula | 54 |
| Total | 113 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 2 | 2 |
| Overall Study | Withdrawal by Subject | 13 | 13 |
Baseline characteristics
| Characteristic | Type of Formula: CMF | Total | Type of Formula: EHF |
|---|---|---|---|
| Age, Continuous | 0.4 Months STANDARD_DEVIATION 0.1 | 0.4 Months STANDARD_DEVIATION 0.1 | 0.4 Months STANDARD_DEVIATION 0.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 13 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 54 Participants | 100 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 35 Participants | 70 Participants | 35 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 18 Participants | 11 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 25 Participants | 8 Participants |
| Region of Enrollment United States | 59 participants | 113 participants | 54 participants |
| Sex: Female, Male Female | 28 Participants | 57 Participants | 29 Participants |
| Sex: Female, Male Male | 31 Participants | 56 Participants | 25 Participants |
| TAS2R38 genotype, A49P allele; infants AA, homozygous recessive | 19 Participants | 34 Participants | 15 Participants |
| TAS2R38 genotype, A49P allele; infants AP, heterozygous | 27 Participants | 52 Participants | 25 Participants |
| TAS2R38 genotype, A49P allele; infants PP, homozygous dominant | 13 Participants | 27 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 54 |
| other Total, other adverse events | 0 / 59 | 0 / 54 |
| serious Total, serious adverse events | 0 / 59 | 0 / 54 |
Outcome results
Primary
Energy Balance: Energy Intake From Infant Formula and Other Sources
Energy intake (kcal/day) of infant formula and other sources was determined by three-day weighed bottle intake and records of the infants' intake of any liquid or food other than formula during the three days
Time frame: 0.75, 3.5, 12.5 mos
Population: Intent-to-treat analysis (N=113).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Type of Formula: CMF | Energy Balance: Energy Intake From Infant Formula and Other Sources | Energy Intake from Other Sources, 12.5 mos | 712 kcal per day | Standard Error 51 |
| Type of Formula: CMF | Energy Balance: Energy Intake From Infant Formula and Other Sources | Energy Intake from Formula, 0.75 months | 466 kcal per day | Standard Error 14 |
| Type of Formula: CMF | Energy Balance: Energy Intake From Infant Formula and Other Sources | Energy Intake from Other Sources, 0.75 months | 0 kcal per day | Standard Error 0 |
| Type of Formula: CMF | Energy Balance: Energy Intake From Infant Formula and Other Sources | Energy Intake from Formula, 3.5 mos | 628 kcal per day | Standard Error 21 |
| Type of Formula: CMF | Energy Balance: Energy Intake From Infant Formula and Other Sources | Energy Intake from Other Sources, 3.5 mos | 11 kcal per day | Standard Error 5 |
| Type of Formula: CMF | Energy Balance: Energy Intake From Infant Formula and Other Sources | Energy Intake from Formula, 12.5 mos | 425 kcal per day | Standard Error 50 |
| Type of Formula: EHF | Energy Balance: Energy Intake From Infant Formula and Other Sources | Energy Intake from Other Sources, 3.5 mos | 10 kcal per day | Standard Error 6 |
| Type of Formula: EHF | Energy Balance: Energy Intake From Infant Formula and Other Sources | Energy Intake from Other Sources, 12.5 mos | 863 kcal per day | Standard Error 57 |
| Type of Formula: EHF | Energy Balance: Energy Intake From Infant Formula and Other Sources | Energy Intake from Formula, 3.5 mos | 596 kcal per day | Standard Error 21 |
| Type of Formula: EHF | Energy Balance: Energy Intake From Infant Formula and Other Sources | Energy Intake from Formula, 0.75 months | 383 kcal per day | Standard Error 15 |
| Type of Formula: EHF | Energy Balance: Energy Intake From Infant Formula and Other Sources | Energy Intake from Formula, 12.5 mos | 284 kcal per day | Standard Error 56 |
| Type of Formula: EHF | Energy Balance: Energy Intake From Infant Formula and Other Sources | Energy Intake from Other Sources, 0.75 months | 0 kcal per day | Standard Error 0 |
Comparison: ANOVAs were conducted with group (CMF, EHF) as the between-subjects factor.p-value: <0.05Repeated Measures ANOVA
Primary
Energy Balance: Energy Loss in Stools
Stool EL (kcal/day) was determined from 3-day stool collection by bomb calorimetry at each timepoint
Time frame: 0.75, 3.5, 12.5 mos
Population: Intent-to-treat analysis (N=113).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Type of Formula: CMF | Energy Balance: Energy Loss in Stools | Energy Loss in Stools, 0.75 months | 22.3 kcal per day | Standard Error 3.9 |
| Type of Formula: CMF | Energy Balance: Energy Loss in Stools | Energy Loss in Stools, 3.5 months | 20.7 kcal per day | Standard Error 1.8 |
| Type of Formula: CMF | Energy Balance: Energy Loss in Stools | Energy Loss in Stools, 12.5 months | 27.1 kcal per day | Standard Error 3.2 |
| Type of Formula: EHF | Energy Balance: Energy Loss in Stools | Energy Loss in Stools, 0.75 months | 34.9 kcal per day | Standard Error 4.1 |
| Type of Formula: EHF | Energy Balance: Energy Loss in Stools | Energy Loss in Stools, 3.5 months | 17.0 kcal per day | Standard Error 1.9 |
| Type of Formula: EHF | Energy Balance: Energy Loss in Stools | Energy Loss in Stools, 12.5 months | 33.8 kcal per day | Standard Error 3.4 |
Comparison: Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat samplep-value: 0.02Repeated Measure ANOVA
Primary
Energy Balance: Sleeping Energy Expenditure (SEE)
Postprandial SEE (kcal/day), a proxy for resting energy expenditure in infant, was measured for a minimum of 30 min by open-circuit, indirect calorimetry using a metabolic cart with canopy hood, in a quiet, thermal-neutral room.
Time frame: 0.75, 3.5, 12.5 mos
Population: Intent-to-treat analysis (N=113).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Type of Formula: CMF | Energy Balance: Sleeping Energy Expenditure (SEE) | Sleeping Energy Expenditure (0.75 months) | 206 kcal per day | Standard Error 6 |
| Type of Formula: CMF | Energy Balance: Sleeping Energy Expenditure (SEE) | Sleeping Energy Expenditure, 3.5 months | 329 kcal per day | Standard Error 8 |
| Type of Formula: CMF | Energy Balance: Sleeping Energy Expenditure (SEE) | Sleeping Energy Expenditure, 12.5 months | 507 kcal per day | Standard Error 11 |
| Type of Formula: EHF | Energy Balance: Sleeping Energy Expenditure (SEE) | Sleeping Energy Expenditure (0.75 months) | 201 kcal per day | Standard Error 6 |
| Type of Formula: EHF | Energy Balance: Sleeping Energy Expenditure (SEE) | Sleeping Energy Expenditure, 3.5 months | 321 kcal per day | Standard Error 8 |
| Type of Formula: EHF | Energy Balance: Sleeping Energy Expenditure (SEE) | Sleeping Energy Expenditure, 12.5 months | 509 kcal per day | Standard Error 11 |
Comparison: Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factorp-value: 0.72Repeated Measure ANOVA
Primary
Energy Balance: Total Energy Expenditure (TEE)
TEE (kcal/day) was measured over 7 days at each of the three time points (0.75, 3.5 and12.5 mos) using the doubly labeled water method
Time frame: 0.75, 3.5, 12.5 mos
Population: Intent-to-treat analysis (N=113).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Type of Formula: CMF | Energy Balance: Total Energy Expenditure (TEE) | Total energy expenditure, 0.75 months | 283 kcal per day | Standard Error 18 |
| Type of Formula: CMF | Energy Balance: Total Energy Expenditure (TEE) | Total energy expenditure, 3.5 months | 488 kcal per day | Standard Error 24 |
| Type of Formula: CMF | Energy Balance: Total Energy Expenditure (TEE) | Total energy expenditure, 12.5 months | 859 kcal per day | Standard Error 42 |
| Type of Formula: EHF | Energy Balance: Total Energy Expenditure (TEE) | Total energy expenditure, 0.75 months | 243 kcal per day | Standard Error 19 |
| Type of Formula: EHF | Energy Balance: Total Energy Expenditure (TEE) | Total energy expenditure, 3.5 months | 444 kcal per day | Standard Error 26 |
| Type of Formula: EHF | Energy Balance: Total Energy Expenditure (TEE) | Total energy expenditure, 12.5 months | 858 kcal per day | Standard Error 45 |
Comparison: Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat samplep-value: 0.72Repeated Measure ANOVA
Primary
Growth: Length for Age (LAZ) Z Scores
At each visit, infants were measured to monitor normal growth. These anthropometric data were converted to Length for age Z (LAZ) Z scores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).
Time frame: 0.5 to 12.5 months with followup visit at 18.5 mos
Population: We conducted an intention-to-treat (ITT) analyses on 113 infants regardless of study withdrawal.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Type of Formula: CMF | Growth: Length for Age (LAZ) Z Scores | Length for Age Z score, 1.5 mos | -0.55 Z score | Standard Error 0.14 |
| Type of Formula: CMF | Growth: Length for Age (LAZ) Z Scores | Length for Age Z score, 6.5 mos | -0.05 Z score | Standard Error 0.14 |
| Type of Formula: CMF | Growth: Length for Age (LAZ) Z Scores | Length for Age Z score, 2.5 mos | -0.57 Z score | Standard Error 0.14 |
| Type of Formula: CMF | Growth: Length for Age (LAZ) Z Scores | Length for Age Z score, 7.5 mos | 0.01 Z score | Standard Error 0.14 |
| Type of Formula: CMF | Growth: Length for Age (LAZ) Z Scores | Length for Age Z score, 0.5 mos | -0.49 Z score | Standard Error 0.14 |
| Type of Formula: CMF | Growth: Length for Age (LAZ) Z Scores | Length for Age Z score, 8.5 mos | -0.02 Z score | Standard Error 0.14 |
| Type of Formula: CMF | Growth: Length for Age (LAZ) Z Scores | Length for Age Z score, 3.5mos | -0.36 Z score | Standard Error 0.14 |
| Type of Formula: CMF | Growth: Length for Age (LAZ) Z Scores | Length for Age Z score, 9.5 mos | 0.01 Z score | Standard Error 0.14 |
| Type of Formula: CMF | Growth: Length for Age (LAZ) Z Scores | Length for Age Z score, 12.5 mos | 0.03 Z score | Standard Error 0.14 |
| Type of Formula: CMF | Growth: Length for Age (LAZ) Z Scores | Length for Age Z score, 10.5 mos | 0.01 Z score | Standard Error 0.14 |
| Type of Formula: CMF | Growth: Length for Age (LAZ) Z Scores | Length for Age Z score, 4.5 mos | -0.26 Z score | Standard Error 0.14 |
| Type of Formula: CMF | Growth: Length for Age (LAZ) Z Scores | Length for Age Z score, 11.5 mos | 0.00 Z score | Standard Error 0.14 |
| Type of Formula: CMF | Growth: Length for Age (LAZ) Z Scores | Length for Age Z score, 0.75 mos | -0.56 Z score | Standard Error 0.14 |
| Type of Formula: CMF | Growth: Length for Age (LAZ) Z Scores | Length for Age Z score, 18.5 mos | -0.07 Z score | Standard Error 0.14 |
| Type of Formula: CMF | Growth: Length for Age (LAZ) Z Scores | Length for Age Z score, 5.5 mos | -0.13 Z score | Standard Error 0.14 |
| Type of Formula: EHF | Growth: Length for Age (LAZ) Z Scores | Length for Age Z score, 18.5 mos | -0.22 Z score | Standard Error 0.16 |
| Type of Formula: EHF | Growth: Length for Age (LAZ) Z Scores | Length for Age Z score, 12.5 mos | -0.13 Z score | Standard Error 0.15 |
| Type of Formula: EHF | Growth: Length for Age (LAZ) Z Scores | Length for Age Z score, 0.5 mos | -0.46 Z score | Standard Error 0.14 |
| Type of Formula: EHF | Growth: Length for Age (LAZ) Z Scores | Length for Age Z score, 1.5 mos | -0.48 Z score | Standard Error 0.14 |
| Type of Formula: EHF | Growth: Length for Age (LAZ) Z Scores | Length for Age Z score, 2.5 mos | -0.62 Z score | Standard Error 0.14 |
| Type of Formula: EHF | Growth: Length for Age (LAZ) Z Scores | Length for Age Z score, 3.5mos | -0.43 Z score | Standard Error 0.15 |
| Type of Formula: EHF | Growth: Length for Age (LAZ) Z Scores | Length for Age Z score, 4.5 mos | -0.21 Z score | Standard Error 0.15 |
| Type of Formula: EHF | Growth: Length for Age (LAZ) Z Scores | Length for Age Z score, 5.5 mos | -0.17 Z score | Standard Error 0.15 |
| Type of Formula: EHF | Growth: Length for Age (LAZ) Z Scores | Length for Age Z score, 6.5 mos | -0.17 Z score | Standard Error 0.15 |
| Type of Formula: EHF | Growth: Length for Age (LAZ) Z Scores | Length for Age Z score, 7.5 mos | -0.11 Z score | Standard Error 0.15 |
| Type of Formula: EHF | Growth: Length for Age (LAZ) Z Scores | Length for Age Z score, 8.5 mos | -0.16 Z score | Standard Error 0.15 |
| Type of Formula: EHF | Growth: Length for Age (LAZ) Z Scores | Length for Age Z score, 9.5 mos | -0.19 Z score | Standard Error 0.15 |
| Type of Formula: EHF | Growth: Length for Age (LAZ) Z Scores | Length for Age Z score, 10.5 mos | -0.21 Z score | Standard Error 0.15 |
| Type of Formula: EHF | Growth: Length for Age (LAZ) Z Scores | Length for Age Z score, 11.5 mos | -0.18 Z score | Standard Error 0.15 |
| Type of Formula: EHF | Growth: Length for Age (LAZ) Z Scores | Length for Age Z score, 0.75 mos | 0.59 Z score | Standard Error 0.14 |
p-value: 0.3295% CI: [-0.058, 0.019]Generalized Estimating Equation
Primary
Growth, Weight for Age (WAZ) Z Score
At each visit, infants were weighed to monitor normal growth. These anthropometric data were converted to Weight for age Z (WAZ) Z scores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).
Time frame: 0.5 to 12.5 months with followup visit at 18.5 mos
Population: We conducted an intention-to-treat (ITT) analyses on 113 infants regardless of study withdrawal.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Type of Formula: CMF | Growth, Weight for Age (WAZ) Z Score | Weight for Age Z score, 0.5 mos | -0.36 Z score | Standard Error 0.12 |
| Type of Formula: CMF | Growth, Weight for Age (WAZ) Z Score | Weight for Age Z score, 0.75 mos | -0.41 Z score | Standard Error 0.12 |
| Type of Formula: CMF | Growth, Weight for Age (WAZ) Z Score | Weight for Age Z score, 1.5 mos | -0.38 Z score | Standard Error 0.12 |
| Type of Formula: CMF | Growth, Weight for Age (WAZ) Z Score | Weight for Age Z score, 2.5 mos | -0.34 Z score | Standard Error 0.12 |
| Type of Formula: CMF | Growth, Weight for Age (WAZ) Z Score | Weight for Age Z score, 3.5 mos | -0.14 Z score | Standard Error 0.12 |
| Type of Formula: CMF | Growth, Weight for Age (WAZ) Z Score | Weight for Age Z score, 4.5 mos | 0.07 Z score | Standard Error 0.13 |
| Type of Formula: CMF | Growth, Weight for Age (WAZ) Z Score | Weight for Age Z score, 5.5 mos | 0.18 Z score | Standard Error 0.13 |
| Type of Formula: CMF | Growth, Weight for Age (WAZ) Z Score | Weight for Age Z score, 6.5 mos | 0.29 Z score | Standard Error 0.13 |
| Type of Formula: CMF | Growth, Weight for Age (WAZ) Z Score | Weight for Age Z score, 7.5 mos | 0.38 Z score | Standard Error 0.13 |
| Type of Formula: CMF | Growth, Weight for Age (WAZ) Z Score | Weight for Age Z score, 8.5 mos | 0.50 Z score | Standard Error 0.13 |
| Type of Formula: CMF | Growth, Weight for Age (WAZ) Z Score | Weight for Age Z score, 9.5 mos | 0.51 Z score | Standard Error 0.13 |
| Type of Formula: CMF | Growth, Weight for Age (WAZ) Z Score | Weight for Age Z score, 10.5 mos | 0.54 Z score | Standard Error 0.13 |
| Type of Formula: CMF | Growth, Weight for Age (WAZ) Z Score | Weight for Age Z score, 11.5 mos | 0.52 Z score | Standard Error 0.13 |
| Type of Formula: CMF | Growth, Weight for Age (WAZ) Z Score | Weight for Age Z score, 12.5 mos | 0.52 Z score | Standard Error 0.13 |
| Type of Formula: CMF | Growth, Weight for Age (WAZ) Z Score | Weight for Age Z score, 18.5 mos | 0.56 Z score | Standard Error 0.14 |
| Type of Formula: CMF | Growth, Weight for Age (WAZ) Z Score | Length for Age Z score, 18.5 mos | -0.07 Z score | Standard Error 0.14 |
| Type of Formula: EHF | Growth, Weight for Age (WAZ) Z Score | Length for Age Z score, 18.5 mos | -0.22 Z score | Standard Error 0.16 |
| Type of Formula: EHF | Growth, Weight for Age (WAZ) Z Score | Weight for Age Z score, 0.5 mos | -0.25 Z score | Standard Error 0.13 |
| Type of Formula: EHF | Growth, Weight for Age (WAZ) Z Score | Weight for Age Z score, 7.5 mos | 0.02 Z score | Standard Error 0.13 |
| Type of Formula: EHF | Growth, Weight for Age (WAZ) Z Score | Weight for Age Z score, 0.75 mos | -0.28 Z score | Standard Error 0.13 |
| Type of Formula: EHF | Growth, Weight for Age (WAZ) Z Score | Weight for Age Z score, 11.5 mos | 0.28 Z score | Standard Error 0.13 |
| Type of Formula: EHF | Growth, Weight for Age (WAZ) Z Score | Weight for Age Z score, 1.5 mos | -0.61 Z score | Standard Error 0.13 |
| Type of Formula: EHF | Growth, Weight for Age (WAZ) Z Score | Weight for Age Z score, 8.5 mos | 0.08 Z score | Standard Error 0.13 |
| Type of Formula: EHF | Growth, Weight for Age (WAZ) Z Score | Weight for Age Z score, 2.5 mos | -0.66 Z score | Standard Error 0.13 |
| Type of Formula: EHF | Growth, Weight for Age (WAZ) Z Score | Weight for Age Z score, 18.5 mos | 0.40 Z score | Standard Error 0.15 |
| Type of Formula: EHF | Growth, Weight for Age (WAZ) Z Score | Weight for Age Z score, 3.5 mos | 0.64 Z score | Standard Error 0.13 |
| Type of Formula: EHF | Growth, Weight for Age (WAZ) Z Score | Weight for Age Z score, 9.5 mos | 0.16 Z score | Standard Error 0.13 |
| Type of Formula: EHF | Growth, Weight for Age (WAZ) Z Score | Weight for Age Z score, 4.5 mos | -0.37 Z score | Standard Error 0.13 |
| Type of Formula: EHF | Growth, Weight for Age (WAZ) Z Score | Weight for Age Z score, 12.5 mos | 0.32 Z score | Standard Error 0.13 |
| Type of Formula: EHF | Growth, Weight for Age (WAZ) Z Score | Weight for Age Z score, 5.5 mos | -0.20 Z score | Standard Error 0.13 |
| Type of Formula: EHF | Growth, Weight for Age (WAZ) Z Score | Weight for Age Z score, 10.5 mos | 0.20 Z score | Standard Error 0.13 |
| Type of Formula: EHF | Growth, Weight for Age (WAZ) Z Score | Weight for Age Z score, 6.5 mos | -0.03 Z score | Standard Error 0.13 |
p-value: 0.00195% CI: [-0.0362, -0.0093]Generalized Estimating Equations
Primary
Growth, Weight for Length (WLZ) Z Scores
At each visit, infants were weighed and measured to monitor normal growth. These anthropometric data were converted to weight-for-length (WLZ) Zscores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).
Time frame: 0.5 to 12.5 months with followup visit at 18.5 mos
Population: We conducted an intention-to-treat (ITT) analyses on 113 infants regardless of study withdrawal.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Type of Formula: CMF | Growth, Weight for Length (WLZ) Z Scores | Weight for Length Z, 3.5 mos | 0.22 Z score | Standard Error 0.13 |
| Type of Formula: CMF | Growth, Weight for Length (WLZ) Z Scores | Weight for Length Z, 7.5 mos | 0.59 Z score | Standard Error 0.14 |
| Type of Formula: CMF | Growth, Weight for Length (WLZ) Z Scores | Weight for Length Z, 0.75 mos | -0.12 Z score | Standard Error 0.13 |
| Type of Formula: CMF | Growth, Weight for Length (WLZ) Z Scores | Weight for Length Z, 8.5 mos | 0.76 Z score | Standard Error 0.14 |
| Type of Formula: CMF | Growth, Weight for Length (WLZ) Z Scores | Weight for Length Z, 4.5 mos | 0.39 Z score | Standard Error 0.13 |
| Type of Formula: CMF | Growth, Weight for Length (WLZ) Z Scores | Weight for Length Z, 9.5 mos | 0.71 Z score | Standard Error 0.14 |
| Type of Formula: CMF | Growth, Weight for Length (WLZ) Z Scores | Weight for Length Z, 2.5 mos | 0.24 Z score | Standard Error 0.13 |
| Type of Formula: CMF | Growth, Weight for Length (WLZ) Z Scores | Weight for Length Z, 10.5 mos | 0.76 Z score | Standard Error 0.14 |
| Type of Formula: CMF | Growth, Weight for Length (WLZ) Z Scores | Weight for Length Z, 5.5 mos | 0.42 Z score | Standard Error 0.14 |
| Type of Formula: CMF | Growth, Weight for Length (WLZ) Z Scores | Weight for Length Z, 11.5 mos | 0.72 Z score | Standard Error 0.14 |
| Type of Formula: CMF | Growth, Weight for Length (WLZ) Z Scores | Weight for Length Z, 1.5 mos | 0.24 Z score | Standard Error 0.13 |
| Type of Formula: CMF | Growth, Weight for Length (WLZ) Z Scores | Weight for Length Z, 12.5 mos | 0.70 Z score | Standard Error 0.14 |
| Type of Formula: CMF | Growth, Weight for Length (WLZ) Z Scores | Weight for Length Z, 6.5 mos | 0.52 Z score | Standard Error 0.14 |
| Type of Formula: CMF | Growth, Weight for Length (WLZ) Z Scores | Weight for Length Z, 18.5 mos | 0.80 Z score | Standard Error 0.14 |
| Type of Formula: CMF | Growth, Weight for Length (WLZ) Z Scores | Weight for Length Z, 0.5 mos | -0.26 Z score | Standard Error 0.13 |
| Type of Formula: EHF | Growth, Weight for Length (WLZ) Z Scores | Weight for Length Z, 18.5 mos | 0.68 Z score | Standard Error 0.15 |
| Type of Formula: EHF | Growth, Weight for Length (WLZ) Z Scores | Weight for Length Z, 0.5 mos | -0.12 Z score | Standard Error 0.13 |
| Type of Formula: EHF | Growth, Weight for Length (WLZ) Z Scores | Weight for Length Z, 0.75 mos | 0.13 Z score | Standard Error 0.13 |
| Type of Formula: EHF | Growth, Weight for Length (WLZ) Z Scores | Weight for Length Z, 1.5 mos | -0.17 Z score | Standard Error 0.13 |
| Type of Formula: EHF | Growth, Weight for Length (WLZ) Z Scores | Weight for Length Z, 2.5 mos | -0.17 Z score | Standard Error 0.13 |
| Type of Formula: EHF | Growth, Weight for Length (WLZ) Z Scores | Weight for Length Z, 3.5 mos | -0.38 Z score | Standard Error 0.14 |
| Type of Formula: EHF | Growth, Weight for Length (WLZ) Z Scores | Weight for Length Z, 4.5 mos | -0.24 Z score | Standard Error 0.14 |
| Type of Formula: EHF | Growth, Weight for Length (WLZ) Z Scores | Weight for Length Z, 5.5 mos | -0.36 Z score | Standard Error 0.14 |
| Type of Formula: EHF | Growth, Weight for Length (WLZ) Z Scores | Weight for Length Z, 6.5 mos | 0.18 Z score | Standard Error 0.14 |
| Type of Formula: EHF | Growth, Weight for Length (WLZ) Z Scores | Weight for Length Z, 7.5 mos | 0.20 Z score | Standard Error 0.14 |
| Type of Formula: EHF | Growth, Weight for Length (WLZ) Z Scores | Weight for Length Z, 8.5 mos | 0.29 Z score | Standard Error 0.14 |
| Type of Formula: EHF | Growth, Weight for Length (WLZ) Z Scores | Weight for Length Z, 9.5 mos | 0.40 Z score | Standard Error 0.14 |
| Type of Formula: EHF | Growth, Weight for Length (WLZ) Z Scores | Weight for Length Z, 10.5 mos | 0.46 Z score | Standard Error 0.14 |
| Type of Formula: EHF | Growth, Weight for Length (WLZ) Z Scores | Weight for Length Z, 11.5 mos | 0.51 Z score | Standard Error 0.14 |
| Type of Formula: EHF | Growth, Weight for Length (WLZ) Z Scores | Weight for Length Z, 12.5 mos | 0.52 Z score | Standard Error 0.14 |
p-value: <0.0595% CI: [-0.0363, -0.0002]Generalized Estimating Equation
Secondary
Feeding Behaviors, Maternal Perceptions
Maternal perception of infant feeding behavior, using standardized questionnaires (Infant feeding style questionnaire; IFSQ); values ranged from 1 to 5; higher scores reflect more of that feeding style. Only baseline data reported herein.
Time frame: 0.5 months
Population: Some mothers responded N/A on questions related to restrictive feeding styles and thus score for this subscale could not be computed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Type of Formula: CMF | Feeding Behaviors, Maternal Perceptions | Laissez-Faire Feeding Style, 0.5 mos | 3.1 Units on a scale | Standard Error 0.1 |
| Type of Formula: CMF | Feeding Behaviors, Maternal Perceptions | Restrictive Feeding Style, 0.5 mos | 2.8 Units on a scale | Standard Error 0.1 |
| Type of Formula: CMF | Feeding Behaviors, Maternal Perceptions | Pressure to Eat Feeding Style, 0.5 mos | 2.2 Units on a scale | Standard Error 0.1 |
| Type of Formula: CMF | Feeding Behaviors, Maternal Perceptions | Responsive Feeding Styly, 0.5 mos | 4.1 Units on a scale | Standard Error 0.1 |
| Type of Formula: EHF | Feeding Behaviors, Maternal Perceptions | Responsive Feeding Styly, 0.5 mos | 4.0 Units on a scale | Standard Error 0.1 |
| Type of Formula: EHF | Feeding Behaviors, Maternal Perceptions | Laissez-Faire Feeding Style, 0.5 mos | 3.0 Units on a scale | Standard Error 0.1 |
| Type of Formula: EHF | Feeding Behaviors, Maternal Perceptions | Pressure to Eat Feeding Style, 0.5 mos | 2.4 Units on a scale | Standard Error 0.1 |
| Type of Formula: EHF | Feeding Behaviors, Maternal Perceptions | Restrictive Feeding Style, 0.5 mos | 2.6 Units on a scale | Standard Error 0.2 |